CClinicalTrials.gg
CompletedNCT00117819Updated May 2, 2014

A Study of Brain Imaging With Nuclear Medicine Technology in Individuals With and at Risk for Parkinson's Disease

A Phase 2 interventional study of [123I]ß CIT and SPECT imaging in Parkinsonian Syndrome, sponsored by Institute for Neurodegenerative Disorders. Completed at 1 site in United States. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-05-02.

Sponsored by Institute for Neurodegenerative Disorders · Phase 2, Interventional, and Diagnostic

Phase
Phase 2
Study type
Interventional
Enrollment
232
Allocation
Not applicable
Ages
22 Years and older
Sex
All
01

Study summary

This study involves study participants who have been clinically diagnosed with parkinsonian syndrome or who are at-risk for parkinsonian syndrome, have a family history of parkinsonian syndrome or exposure to environmental toxins potentially associated with parkinsonian syndrome. Participants will have brain imaging to assess dopamine transporter density. The imaging data coupled with family history and environmental exposure data may provide important information about potential risk factors for parkinsonian syndrome.

Read the detailed description

The brain imaging is conducted at the Institute for Neurodegenerative Disorders in New Haven, Connecticut. The imaging procedure occurs over a two day period.

On the first day participants are injected with [123I]ß CIT, an investigational radioactive material that localizes in the brain. Study participants will also have a thorough neurologic examination and standard neuropsychological testing, including testing of memory, concentration, abstraction and visual spatial functions.

Twenty-four hours later study participants return to the Institute for Neurodegenerative Disorders where an investigational scanning procedure will be used to obtain SPECT (single photon emission computed tomography) images of the brain.

Participants may be contacted to repeat these procedures every 12 to 18 months.

02

Conditions studied

  • Parkinsonian Syndrome

Keywords

  • parkinson
  • family history
  • diagnosis
03

In context

Parkinsonian Disorders

235 studies on the registry are indexed under Parkinsonian Disorders; 69 are open to participants now.

This study's enrollment of 232 is above the median of 55 across 143 interventional studies indexed under Parkinsonian Disorders.

Browse Parkinsonian Disorders studies →

Lead sponsor

Institute for Neurodegenerative Disorders is the lead sponsor of 40 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 22 years or older
  • A clinical diagnosis of Parkinson's disease (PD), positive family history of PD and/or potential exposure to environmental toxins
  • Normal screening laboratory studies

Exclusion criteria

Exclusion Criteria:

  • Pregnancy
  • Psychiatric disease other than history of depression
  • Significant medical disease including abnormalities on screening
05

Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
232 participants (actual)

Study arms

  • Experimental
    [123I]ß CIT and SPECT imaging

    To assess \[123I\]ß-CIT and SPECT imaging

    Drug: [123I]ß CIT and SPECT imaging

Interventions

  • Drug[123I]ß CIT and SPECT imaging

    To assess \[123I\]ß CIT and SPECT imaging

    Also known as: [123I]ß CIT, SPECT imaging

06

What researchers measure

Primary outcomes

  1. CIT uptake is the Specific: Nondisplaceable striatal uptake ratio

    Time frame: 2 yrs

Secondary outcomes

  1. CIT uptake measures from at-risk individuals will be compared with healthy subjects.

    Time frame: 2 yrs

07

Study locations

1 site
  • Institute for Neurodegenerative Disorders
    New Haven, Connecticut 06510, United States
08

References and documents

Publications

  • Koller WC, Langston JW, Hubble JP, Irwin I, Zack M, Golbe L, Forno L, Ellenberg J, Kurland L, Ruttenber AJ, et al. Does a long preclinical period occur in Parkinson's disease? Neurology. 1991 May;41(5 Suppl 2):8-13. No abstract available. PubMed 2041599 ↗
  • Marek, K., J. Seibyl, et al. (1999). "[123I] ß-CIT/SPECT: Assessment of determinants of variability in progression of Parkinson's disease." Neurology 52: A91-92.
  • Marek, K., J. Seibyl, et al. (1996). "Dopamine transporter and receptor imaging in Parkinsonism. (Presented at the 4th International Congress of Movement Disorders, Vienna, Austria; June, 1996.)." Mov Dis 6.
  • Morrish PK, Sawle GV, Brooks DJ. An [18F]dopa-PET and clinical study of the rate of progression in Parkinson's disease. Brain. 1996 Apr;119 ( Pt 2):585-91. doi: 10.1093/brain/119.2.585. PubMed 8800950 ↗
  • Seibyl JP, Marek KL, Quinlan D, Sheff K, Zoghbi S, Zea-Ponce Y, Baldwin RM, Fussell B, Smith EO, Charney DS, van Dyck C, et al. Decreased single-photon emission computed tomographic [123I]beta-CIT striatal uptake correlates with symptom severity in Parkinson's disease. Ann Neurol. 1995 Oct;38(4):589-98. doi: 10.1002/ana.410380407. Erratum In: Ann Neurol. 1996 Mar;39(3):417. van Dyck, C [added]. PubMed 7574455 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00117819
Lead sponsor
Institute for Neurodegenerative Disorders
Collaborators
Indiana University, Albany Medical College
Responsible party
Kenneth Marek, MD (Principal Investigator, Institute for Neurodegenerative Disorders) — Principal investigator
First posted
Jul 8, 2005
Start date
Mar 2001
Primary completion
Jan 2013
Completion
Jan 2013
Last update
May 2, 2014

Study contacts

Kenneth L. Marek, MD
principal investigator · President and Senior Scientist

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion